The Effect of Online Cognitive Awareness-Based Nursing Support for Premenopausal Women on Vasomotor Symptoms, Stress and Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Personal Information Form
Study Overview
Brief Summary
This randomized controlled study was conducted at Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital between 16.05.2022-30.06.2023. Research data were collected at the gynecology outpatient clinic. The sample of the study consisted of 74 (37-intervention, 37-control) premenopausal women who met the inclusion criteria and were placed by randomization. The data of the study were collected using "Personal Information Form, Mindful Attention Awareness Scale (MAAS), Visual Analogue Scale for Vasomotor Symptoms (VAS), Perceived Stress Scale (PSS) and Menopause-Specific Quality of Life Scale (MENQOL)". First, the pretests of the study were applied to women in the intervention and control groups. Afterwards, women in the intervention group underwent the MenoMind program for eight weeks, and women in the control group were left with routine clinical care. In the eighth week of the research, the "MenoMind Evaluation Form" was applied to the women in the intervention group to evaluate the MenoMind program. One month after the study was completed, post-tests were performed on the intervention and control groups.
Detailed Description
METHOD Purpose of the research This study aims to examine the effect of online cognitive awareness-based nursing support (MenoMind) for premenopausal women on vasomotor symptoms, stress and quality of life.
Type of research This study was planned as a randomized controlled experimental study. The study was conducted according to CONSORT guidelines.
Hypotheses of the research Hypothesis 1: MenoMind program increases the conscious awareness level of premenopausal women.
Hypothesis 2: The MenoMind program reduces vasomotor symptoms of premenopausal women.
Hypothesis 3: The MenoMind program reduces the stress level of premenopausal women.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Being able to read and write,
- •Being able to use the internet,
- •Having a device that can use the internet (such as a smartphone or computer),
- •Not having a diagnosed psychiatric disease,
- •Not having a chronic disease
- •Not using hormone replacement therapy,
- •Age 40 and above and having symptoms of menstrual irregularity,
- •Receiving an average score of two or more from Menopause-Specific Quality of Life Scale,
- •Scoring three or more on the Visual Analogue Scale for Vasomotor Symptoms
Exclusion Criteria
- •There are situations that prevent the exercises from being performed,
- •Participating in a mindfulness training program before.
Arms & Interventions
Control
The control group received no intervention and the women were left to routine clinical care.
Experimental: Intervention
An online mindfulness nursing support program (MenoMind) was applied to this group for 8 weeks and lasting an average of 50 minutes.
Intervention: MenoMind intervention group (Other)
Outcomes
Primary Outcomes
Personal Information Form
Time Frame: 5th minute
The personal information form, created in line with the literature, aims to determine the socio-demographic characteristics of women in the premenopausal period; It is a form consisting of 13 items containing descriptive information specific to the individual (age, education, marital status, employment status, income level, vasomotor symptoms, smoking status and regular exercise status).
Secondary Outcomes
- Menopause-Specific Quality of Life Scale (MENQOL)(10th minute)
- Perceived Stress Scale (PSS)(5th minute)
- Visual Analog Scale for Vasomotor Symptoms (VAS)(2th minute)
- Mindful Attention Awareness Scale (MAAS)(5th minute)
Investigators
Fatma Aslan Demirtaş
Research Assistant
Bandırma Onyedi Eylül University